Desoximetasone

DESOXIMETASONE- desoximetasone spray
Perrigo New York Inc

1 INDICATIONS AND USAGE

Desoximetasone Topical Spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

2 DOSAGE AND ADMINISTRATION

Apply Desoximetasone Topical Spray, 0.25% as a thin film to the affected skin areas twice daily. Rub in gently.

The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician.

Desoximetasone Topical Spray, 0.25% should be discontinued when control is achieved.

Treatment beyond 4 weeks is not recommended.

Do not use if atrophy is present at the treatment site.

Avoid use on the face, axilla or groin.

Desoximetasone Topical Spray, 0.25% is for external use only. It is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Topical Spray, 0.25%. Each gram of Desoximetasone Topical Spray, 0.25% contains 2.5 mg of desoximetasone in a clear, colorless liquid.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Effect on Endocrine System

Desoximetasone Topical Spray, 0.25% is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with desoximetasone topical spray, 0.25% twice a day for 28 days. [see Clinical Pharmacology (12.2) ]

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4) ]

5.2 Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.4 Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Desoximetasone Topical Spray, 0.25% should be discontinued until the infection has been adequately treated.

5.5 Flammable Contents

Desoximetasone Topical Spray, 0.25% is flammable; keep away from heat or flame.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied desoximetasone topical spray, 0.25% or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied desoximetasone topical spray, 0.25%.

Adverse reactions that occurred in ≥ 1% of subjects treated with desoximetasone topical spray, 0.25% were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).

Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1%

Desoximetasone Topical Spray, 0.25%

b.i.d.

(N = 149)

Vehicle spray

b.i.d.

(N = 135)

Number of Subjects with Adverse Reactions

13 (8.7%)

18 (13.3%)

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

Application site pruritus

3 (2.0%)

5 (3.7%)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women.

Desoximetasone Topical Spray, 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of desoximetasone topical spray, 0.25% based on a body surface area comparison.

8.3 Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Desoximetasone Topical Spray, 0.25% is administered to a nursing woman.

If used during lactation, Desoximetasone Topical Spray, 0.25% should not be applied on the chest to avoid accidental ingestion by the infant.

Page 1 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.